The REPRISE Project: Protocol For An Evaluation Of .

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Page et al. Systematic Reviews(2021) OTOCOLOpen AccessThe REPRISE project: protocol for anevaluation of REProducibility andReplicability In Syntheses of EvidenceMatthew J. Page1* , David Moher2,3, Fiona M. Fidler4,5, Julian P. T. Higgins6, Sue E. Brennan1,Neal R. Haddaway7,8,9,10, Daniel G. Hamilton4, Raju Kanukula1, Sathya Karunananthan11, Lara J. Maxwell12,Steve McDonald1, Shinichi Nakagawa13, David Nunan14, Peter Tugwell3,15,16, Vivian A. Welch3,16 andJoanne E. McKenzie1AbstractBackground: Investigations of transparency, reproducibility and replicability in science have been directed largelyat individual studies. It is just as critical to explore these issues in syntheses of studies, such as systematic reviews,given their influence on decision-making and future research. We aim to explore various aspects relating to thetransparency, reproducibility and replicability of several components of systematic reviews with meta-analysis of theeffects of health, social, behavioural and educational interventions.Methods: The REPRISE (REProducibility and Replicability In Syntheses of Evidence) project consists of four studies.We will evaluate the completeness of reporting and sharing of review data, analytic code and other materials in arandom sample of 300 systematic reviews of interventions published in 2020 (Study 1). We will survey authors ofsystematic reviews to explore their views on sharing review data, analytic code and other materials and theirunderstanding of and opinions about replication of systematic reviews (Study 2). We will then evaluate the extentof variation in results when we (a) independently reproduce meta-analyses using the same computational stepsand analytic code (if available) as used in the original review (Study 3), and (b) crowdsource teams of systematicreviewers to independently replicate a subset of methods (searches for studies, selection of studies for inclusion,collection of outcome data, and synthesis of results) in a sample of the original reviews; 30 reviews will bereplicated by 1 team each and 2 reviews will be replicated by 15 teams (Study 4).Discussion: The REPRISE project takes a systematic approach to determine how reliable systematic reviews ofinterventions are. We anticipate that results of the REPRISE project will inform strategies to improve the conductand reporting of future systematic reviews.Keywords: Reproducibility of Results, Replication, Transparency, Systematic reviews, Meta-analysis, Methodology,Quality* Correspondence: matthew.page@monash.edu1School of Public Health and Preventive Medicine, Monash University, 553 St.Kilda Road, Melbourne, Victoria 3004, AustraliaFull list of author information is available at the end of the article The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License,which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you giveappropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate ifchanges were made. The images or other third party material in this article are included in the article's Creative Commonslicence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commonslicence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtainpermission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.The Creative Commons Public Domain Dedication waiver ) applies to thedata made available in this article, unless otherwise stated in a credit line to the data.

Page et al. Systematic Reviews(2021) 10:112BackgroundMany researchers have expressed alarm at the variationin results of systematic attempts to come up with thesame answer to the same research question [1]. Therehave been frequent failures to obtain the same resultswhen reanalysing the data collected in a study using thesame computational steps and analytic code as the original study (this is usually referred to as a lack of ‘reproducibility’) [2–4]. Similarly, results have often differedwhen conducting a new study designed to address thesame question(s) of a prior study (this is usually referredto as a lack of ‘replicability’) [5–7]. Concerns about reproducibility and replicability have led to efforts to enhance the ‘transparency’ of studies, by guiding authorsto improve the reporting of methods and make theunderlying materials, such as data and analytic code,publicly accessible [8, 9]. Investigations of transparency,reproducibility, and replicability in research have beendirected largely at primary studies [2, 10–17]. However,such issues are also critical for systematic reviews—which attempt to locate and synthesise findings from allstudies addressing a particular question—given their influence on decision-making and future research [18].A reproduction or replication of an original systematicreview might yield different results for various reasons.For example, authors of an original review might havemade errors throughout the review process, by failing toinclude an eligible study, or entering study data incorrectlyin a meta-analysis. Alternatively, different results mightarise due to different judgements made by review teamsabout how best to identify studies, which studies to include, which data to collect and how to synthesise results[19–23]. Understanding the extent to which results of systematic reviews vary when analyses are reproduced or theentire review process is replicated, and the reasons why,can help establish how reliable and valid synthesis findingsare likely to be in general. Such knowledge can also provide comparative evidence on the value of different systematic review methods. For example, replicationsdesigned to evaluate the impact of using automation toolsor abbreviated methods (such as having only one authorscreen articles to speed up the process) could help revealwhat risks the use of such methods entail, if any, whencompared to traditional methods [24].The few previous investigations of the transparency,reproducibility, and replicability of systematic reviewsand meta-analyses differ in scope. Some have evaluatedtransparency of published reviews, documenting howoften systematic reviewers report methods completely(i.e., in sufficient detail to allow others to repeat them),or share review data, analytic code, and other materials(e.g., [25–30]). Some investigators have re-extracted datafrom studies included in a sample of published systematic reviews and documented any inconsistencies withPage 2 of 13data included in the original meta-analyses and with therecalculated meta-analytic effect estimate (e.g. [20, 31–34]). There have also been some cases where two independent review teams were contracted to conduct systematic reviews addressing the same question concurrently, tosee if consistent results were obtained (e.g. [35, 36]). Theseinvestigations provide some insight into the extent oftransparency, reproducibility and replicability of systematic reviews, but have been narrow in scope, focusing onlyon one aspect of the review process, or restricting inclusion to one type of review (e.g. Cochrane reviews) or to reviews with one type of included study (e.g. randomisedtrials of drugs, or psychology experiments).Available research on the transparency, reproducibilityand replicability of systematic reviews leaves many questions unanswered. We do not know the extent to whichcompleteness of reporting is associated with replicabilityof systematic reviews. It is unclear to what extent factorssuch as journal policies are associated with sharing ofdata, analytic code and other materials in systematic reviews, and what facilitators or barriers exist towards reviewers adopting them. We do not know what stages ofthe systematic review process, such as the search, selection, data collection or synthesis, are most prone to discrepancies between an original and replicated review. Toaddress these gaps, we aim to explore various aspects relating to the transparency, reproducibility and replicability of several components of systematic reviews withmeta-analysis of the effects of health, social, behaviouraland educational interventions. Specifically, the objectivesof the project are to evaluate in a sample of systematicreviews of interventions:1. How frequently methods are reported completely,and how often review data, analytic code and othermaterials (e.g. list of all citations screened, datacollection forms) are made publicly available;2. Systematic reviewers’ views on sharing review data,analytic code and other materials and theirunderstanding of and opinions about replication ofreviews;3. The extent of variation in results whenindependently reproducing meta-analyses using thesame computational steps and analytic code (ifavailable) as used in the original review; and4. The extent of variation in results when replicatingthe search, selection, data collection and analysisprocesses of an original review.MethodsOverviewThe REPRISE (REProducibility and Replicability In Syntheses of Evidence) project consists of a suite of studiesto address our four objectives (Fig. 1). We will evaluate

Page et al. Systematic Reviews(2021) 10:112Page 3 of 13Fig. 1 REPRISE project componentsthe completeness of reporting and sharing of review materials in a random sample of 300 systematic reviewswith meta-analysis published in 2020 (Study 1). We willsurvey authors of systematic reviews to explore theirviews on sharing review data, analytic code and othermaterials and their understanding of and opinions aboutreplication of systematic reviews (Study 2). We will thenevaluate the extent of variation in results when we (a) independently reproduce meta-analyses using the samecomputational steps and analytic code (if available) asused in the original review (Study 3), and (b) crowdsource teams of systematic reviewers to independentlyreplicate a subset of methods (searches for studies, selection of studies for inclusion, collection of outcome data,and synthesis of results) in a sample of the original reviews; 30 reviews will be replicated by 1 team each and 2reviews will be replicated by 15 teams (Study 4).We will focus on systematic reviews of the effectsof health, social, behavioural and educational interventions. Eligible interventions will include any intervention designed to improve health (definedaccording to the World Health Organisation as “astate of complete physical, mental and social wellbeing and not merely the absence of disease or infirmity” [37]), promote social welfare and justice,change behaviour or improve educational outcomes.Examples of eligible interventions include inhaled corticosteroids to alleviate symptoms of asthma,provision of charity or welfare to alleviate social oreconomic problems, provision of regulations to improve safety in workplaces, use of bystander programsto prevent violence or harassment, or reduction ofclass size to enhance educational outcomes for highschool students.

Page et al. Systematic Reviews(2021) 10:112Study 1: Evaluation of the transparency of systematicreviews with meta-analysisThe objective of this study is to evaluate the completeness of reporting and sharing of review data, analyticcode and other materials (e.g. list of all citationsscreened, data collection forms) in systematic reviewswith meta-analysis. We will do this by conducting across-sectional evaluation of systematic reviews published in 2020.Identification of systematic reviewsWe will include a random sample of completed systematic reviews with meta-analysis in our evaluation. To beconsidered a “systematic review”, authors will need tohave, at a minimum, clearly stated their review objective(s) or question(s), reported the source(s) (e.g. bibliographic databases) used to identify studies meeting theeligibility criteria, and reported conducting an assessment of the validity of the findings of the included studies, for example via an assessment of risk of bias ormethodological quality. We will not exclude articles providing limited detail about the methods used (e.g. articles will be considered eligible if they provide only a listof the key words used in bibliographic databases ratherthan a line-by-line Boolean search strategy). Systematicreviews with meta-analysis meeting the following additional criteria will be eligible for inclusion in the study: Written in English, indexed in the most recent 1-month period closest to when the search for thepresent study is run, in one of the following bibliographic databases in the health and social sciences:PubMed, Education Collection via Proquest, Scopusvia Elsevier and Social Sciences Citation Index andScience Citation Index Expanded via Web ofScience; Includes randomised or non-randomised studies (orboth) evaluating the effects of a health, social, behavioural or educational intervention on humans; Lists the references for all studies included in thereview; and Presents at least one pairwise meta-analysis of aggregate data, including at least two studies, using anyeffect measure (e.g. mean difference, risk ratio).Using search strategies created by an information specialist (SM), we will systematically search each databaselisted above for systematic reviews with meta-analysismeeting the eligibility criteria. For example, we will runthe following search in PubMed: (meta-analysis[PT] ORmeta-analysis[TI] OR systematic[sb]) AND 2020/11/02:2020/12/02[EDAT]. Search strategies for other databasesare available in Additional file 1. We will download allrecords and remove duplicates using Endnote software,Page 4 of 13export the unique records to Microsoft Excel and randomly sort them using the RAND() function, then import the first 500 randomly sorted records intoCovidence software [38] for screening. Two investigatorswill independently screen the titles and abstracts inbatches of 500, retrieve any potentially eligible reportsand independently assess each report against the eligibility criteria. This process will be repeated until we reacha target of 300 eligible systematic reviews. In the unlikelyevent that we do not reach our target of 300 reviewsafter screening all records yielded from the search, wewill rerun the search to identify records published in thesubsequent 1-month period and repeat the screeningsteps described above. We will include systematic reviews regardless of whether the question(s) they addressare also addressed by another systematic review in thesample. Including 300 systematic reviews will allow us toestimate the percentage of reviews reporting a particularpractice (e.g. reporting the full line-by-line search strategy) to within a maximum margin of error of 6% assuming a prevalence of 50% (i.e. 1.96* (0.5*(1 0.5)/300)); fora prevalence of less (or greater) than 50%, the margin oferror will be smaller.Data collectionTwo investigators will independently and in duplicate collect information about each systematic review using a standardised data collection form. Any discrepancies in the datacollected will be resolved via discussion or adjudication byanother investigator. Prior to data collection, both investigators will pilot test the data collection form on a randomsample of 10 systematic reviews within the set of 300, discuss any discrepancies and adjust the form where necessary. The form will include items capturing generalcharacteristics of the review (e.g. journal it is published in,country of corresponding author, intervention under investigation, number of included studies) and items that characterise, for example, whether systematic reviewers: Reported the complete line-by-line search strategyused for at least one (or for each) electronic databasesearched; Reported the process for selecting studies, collectingdata and assessing risk of bias/quality in theincluded studies; Presented the summary statistics, effect estimatesand measures of precision (e.g. confidence intervals)for each study included in the first meta-analysis reported in the review; and Made data files and analytic code publicly available,and if so, specified how to access them.We will evaluate the main systematic review report,any supplementary files provided on the journal server

Page et al. Systematic Reviews(2021) 10:112or in a public or institutional repository, or the reviewprotocol if the authors specify that the relevant information is contained therein. The wording of items will beidentical to that used in previous evaluations of this nature [25, 39] to allow investigation of improvements intransparency over time. We will record whether authorsspecified using a guideline such as the 2009 PRISMAstatement [40] to guide reporting. We will also searchthe websites of the journals that published the includedsystematic reviews, and record whether or not they havea data or code sharing policy, or both, that is, a requestthat authors of all research articles or systematic reviewsin particular share their data (or analytic code) whenthey submit an article [16]. If such a policy exists, wewill extract it verbatim and classify it as “mandatory”(i.e. sharing data or analytic code, or both, is a conditionof publication of systematic reviews by the journal) or“desirable” (i.e. authors are advised to share data or analytic code, but failing to do so will not preclude publication of systematic reviews).Data analysisWe will characterise indicators of transparency in thesystematic reviews using descriptive statistics (e.g. frequency and percentage for categorical items and meanand standard deviation for continuous items). We willuse risk ratios with 95% confidence intervals to examinedifferences in percentages of each indicator between reviews published in a journal that publishes evidence syntheses only (e.g. Cochrane Database of SystematicReviews, Campbell Systematic Reviews, JBI Evidence Synthesis) versus published elsewhere; between the 2020 reviews of health interventions and a previously examinedsample of 110 systematic reviews of health interventionsindexed in MEDLINE in February 2014 [25, 39]; between reviews with self-reported use of a reportingguideline versus without; and between reviews publishedin journals with versus without any data or code sharingpolicy, and with versus without a mandatory data orcode sharing policy.Study 2: Evaluation of systematic reviewers’ views onsharing review data, analytic code and other materialsand on the replication of reviewsThe objective of this study is to explore systematic reviewers’ views on sharing review data, analytic code andother materials (e.g. list of all citations screened, datacollection forms) and their understanding of and opinions about replication of systematic reviews. We willgather systematic reviewers’ views via an online survey.Recruitment of systematic reviewersTwo investigators will independently screen theremaining titles and abstracts identified in Study 1 forPage 5 of 13inclusion in Study 2. We will invite all corresponding authors of systematic reviews of the effects of health, social, behavioural or educational interventions that meetthe inclusion criteria for Study 1 to complete the survey,excluding authors of the randomly selected subsample of300. The reason for excluding this subsample is to reduce author burden, since these authors will be contacted in Study 3. We will contact authors via email andsend up to three reminders separated by 3 weeks in caseof non-response. The survey will be administered viaQualtrics (Qualtrics, Provo, UT, USA).Survey contentThe survey will capture demographic characteristics ofthe systematic reviewers (e.g. country of residence, career stage, number of systematic reviews conducted, areasof expertise) and their views on the open science movement. We will include questions asking authors to indicate the extent to which they agree that:(i) Systematic reviewers should share review data,analytic code and other materials routinely;(ii) Potential facilitators or barriers apply to the sharingof systematic review material, which we will drawfrom previous studies examining facilitators andbarriers to adopting open science practices [41–47].Responses will be collected via a 7-point Likert scaleranging from ‘strongly disagree’ to ‘strongly agree’. Authors will be given an opportunity to suggest other materials they believe systematic reviewers should share,and facilitators or barriers not listed in the survey. Finally, we will gauge authors’ understanding of and opinions about replication of systematic reviews, adaptingthe questions asked in previous studies evaluating researchers’ views on replication studies [48–50].Data analysisWe will analyse quantitative survey data by calculatingthe frequency and percentage for each response optionfor each question. We will use a deductive approach tocoding of free-text responses to survey questions [51].First, we will read each line of text and label it with acode that represents the meaning of the text; the initialcodes will be informed by our prior work conducted todraft survey items. As each subsequent line of text isread, existing codes will be revised, where necessary, andnew codes added, to ensure consistency of coding acrossresponses. We will then organise codes into overarchingthemes. One investigator will perform the coding of textand categorisation of codes into themes, which will beverified by another investigator.

Page et al. Systematic Reviews(2021) 10:112Study 3: Evaluation of the reproducibility of metaanalysesThe objective of this study is to evaluate the reproducibility of meta-analyses. We will do this by evaluating theextent of variation in results when we independently reproduce meta-analyses using the same computationalsteps and analytic code (if available) as used in the original review.Sampling frameWe will include in this study all systematic reviews identified in Study 1 where the reviewers made available thedata necessary to reproduce the first meta-analysis reported in the review, henceforth referred to as the “indexmeta-analysis”. If the systematic reviewers uploaded relevant data files (e.g. a Microsoft Excel or CSV spreadsheet, or a RevMan file containing all study effectestimates included in the index meta-analysis) or analytic code as a supplement to the paper, or reported alink to a publicly accessible repository (e.g. Open ScienceFramework, Dryad, figshare) or a website containingrelevant files, we will download the files deposited. If nosuch files are referred to within the review report, or ifthe links to files are broken, we will invite the corresponding author of the review to share their systematicreview data file(s) and analytic code for the purposes ofreproduction, record what materials were shared, and request reasons for non-availability if materials were notshared. If no data file is made publicly accessible, one investigator will extract the study effect estimates includedin the index meta-analysis from the relevant table or figure (e.g. forest plot) reported in the review. We will notextract or check for accuracy the data in reports of theincluded studies.We anticipate obtaining data files (as a supplementaryfile to the paper, or from a public repository or the systematic reviewers) for at least 90 (30%) of the 300 reviews. In 2018, colleagues performing another studysought the aggregated data from 200 interrupted timeseries studies published from 2013 to 2017; they obtained the necessary data for 30% of studies from thestudy authors or as a supplementary file to the paper[52]. It is possible that the response rate will be higherin our study given the shorter time span between publication and us making the request (which will be lessthan 1-year post-publication).Reproduction of meta-analysesTwo investigators will independently carry out a reanalysis of the index meta-analysis of the review using thedata available. For each meta-analysis, we will conductthe reanalysis according to the methods described in thepublished report of the review, regardless of how appropriate we consider the methods. If unable to conduct thePage 6 of 13reanalysis based on the data available and methods described, we will seek clarification from the systematic reviewers, and attempt to reanalyse the data based on theadditional information provided. Each reanalysis will beconducted using the same statistical software packageand version used by the original systematic reviewers,where possible. If systematic reviewers shared their analytic code, we will use it without modification. If no analytic code was shared, or if we are unable to access thesoftware package and version used by the original systematic reviewers, we will write the code necessary to reanalyse the data ourselves, using the metafor package[53] in the open source statistical software R (R Development Core Team), based on the statistical methods described by the reviewers. We will record for eachreanalysis the meta-analytic estimate of effect, its corresponding 95% confidence interval, and inferences aboutheterogeneity (Cochran’s Q and its P value, I2, tau2 anda prediction interval).Two investigators will independently classify eachindex meta-analysis into one of three reproducibilitycategories:(i) ‘Results fully reproducible’ (i.e. no difference [withallowance for trivial discrepancies such as those dueto computational algorithms] is observed betweenthe original and recalculated meta-analytic effect estimate, its 95% confidence interval and inferencesabout heterogeneity reported in the original review);(ii) ‘Results not fully reproducible’ (i.e. a difference[even after allowance for trivial discrepancies] isobserved between the original and recalculatedmeta-analytic effect estimate, its 95% confidenceinterval or inferences about heterogeneity reportedin the original review, or;(iii)‘Results not able to be reproduced because ofmissing information’.Two investigators will also independently specifywhether they believe the observed difference betweenthe original and recalculated summary estimate and itsprecision was meaningful, that is, would lead to a changein the interpretation of the results (classified as ‘difference meaningful’ or ‘difference not meaningful’). Anydiscrepancies in the classifications assigned by the twoinvestigators will be resolved via discussion or adjudication by another investigator on the project. We will alsorecord any difficulties in obtaining and using the authorsupplied data or analytic code.Data analysisWe will calculate the frequency and percentage (with95% confidence interval) of (i) systematic reviews forwhich a data file was made publicly accessible, (ii)

Page et al. Systematic Reviews(2021) 10:112systematic reviews for which analytic code was madepublicly accessible, (iii) meta-analyses classified as havingfully reproducible results without involvement of the original reviewer; (iv) meta-analyses classified as havingfully reproducible results with involvement of the original reviewer, and; (v) differences between the originaland recalculated summary estimate and its precision thatwere classified as meaningful. We will calculate agreement between the original and recalculated metaanalytic effects, displayed using Bland-Altman plots [54],and tabulate discordance between P values for the metaanalytic effects, by categorising the P values based oncommonly used levels of statistical significance, namelyP 0.01; 0.01 P 0.05; 0.05 P 0.1; P 0.1. We willalso classify any difficulties in obtaining and using theauthor-supplied data or analytic code into conceptuallyrelated themes to generate a list of common challengesexperienced.Study 4: Evaluation of the replicability of systematicreviewsThe objective of this study is to evaluate the replicabilityof systematic reviews. We will do this by evaluating theextent of variation in results when we crowdsourceteams of systematic reviewers to independently replicatethe searches for studies, selection of studies for inclusionin the review, collection of outcome data from studiesand synthesis of results in a sample of the original reviews. By ‘crowdsource’ we mean recruiting a largegroup of individuals to complete the systematic reviewtasks [55–57].We recognise that the terminology for ‘replication’ isnot standardised within and across disciplines [7, 58]. Inthis study, we will adopt the non-procedural definitionsof replication advocated by Nosek and Errington [5] andMachery [6]; that is, replicators will not need to followevery single step exactly as reported in the original systematic review, but they will be constrained by the original review question and must avoid making changes tothe methods and concepts that might be reasonablyjudged to violate an attempt to answer that question.Sampling frameWe will use as our initial sampling frame the systematicreviews identified in Study 1 where the index (first reported) meta-analysis was reported completely. Specifically, meta-analyses in which the summary statistics (e.g.means and standard deviations per group) or an effectestimate (e.g. mean difference) and measure of precision(e.g. 95% confidence interval) were presented numerically for each study in a table or figure. We anticipate thatsuch details will be available in at least 225 (75%) of the300 systematic reviews, based on observations in previous evaluations of systematic reviews in medicine [25,Page 7 of 1326] and psychology [30, 32]. For reasons of feasibility,we will then restrict the sampling frame to those reviewsthat included 5–10 studies in the index meta-analysis(which is likely to be the case in half of the reviews[39]), and in which searches of databases, registers orwebsites were carried out in English only.

transparency, reproducibility and replicability of several components of systematic reviews with meta-analysis of the effects of health, social, behavioural and educational interventions. Methods: The REPRISE (REProducibility and Replicability In

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